RenovaRP GIS-35
GUDID 00893029002731
The RenovaRP® Centesis Pump is intended to be used in conjunction with the RenovaRP Tube Set and the RenovaRP Fluid Drainage Bags to remove ascitic fluid from the abdominal cavity for paracentesis, and remove pleural effusion from the thoracic cavity for thoracentesis. The RenovaRP Centesis Pump is intended to be used by medically trained healthcare professionals knowledgeable about paracentesis and thoracentesis.
GI Supply, Inc.
Surgical suction pump Surgical suction pump Surgical suction pump Surgical suction pump Surgical suction pump Surgical suction pump Surgical suction pump Surgical suction pump Surgical suction pump Surgical suction pump Surgical suction pump Surgical suction pump Surgical suction pump Surgical suction pump Surgical suction pump Surgical suction pump Surgical suction pump| Primary Device ID | 00893029002731 |
| NIH Device Record Key | 6e18933d-a535-419d-8ce8-a94f0c75de8b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RenovaRP |
| Version Model Number | GIS-35 |
| Catalog Number | GIS-35 |
| Company DUNS | 160990313 |
| Company Name | GI Supply, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 800-451-5797 |
| customer_service@gi-supply.com | |
| Phone | 800-451-5797 |
| customer_service@gi-supply.com | |
| Phone | 800-451-5797 |
| customer_service@gi-supply.com | |
| Phone | 800-451-5797 |
| customer_service@gi-supply.com | |
| Phone | 800-451-5797 |
| customer_service@gi-supply.com | |
| Phone | 800-451-5797 |
| customer_service@gi-supply.com | |
| Phone | 800-451-5797 |
| customer_service@gi-supply.com | |
| Phone | 800-451-5797 |
| customer_service@gi-supply.com | |
| Phone | 800-451-5797 |
| customer_service@gi-supply.com | |
| Phone | 800-451-5797 |
| customer_service@gi-supply.com | |
| Phone | 800-451-5797 |
| customer_service@gi-supply.com | |
| Phone | 800-451-5797 |
| customer_service@gi-supply.com | |
| Phone | 800-451-5797 |
| customer_service@gi-supply.com | |
| Phone | 800-451-5797 |
| customer_service@gi-supply.com | |
| Phone | 800-451-5797 |
| customer_service@gi-supply.com | |
| Phone | 800-451-5797 |
| customer_service@gi-supply.com | |
| Phone | 800-451-5797 |
| customer_service@gi-supply.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00893029002731 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K221042
FDA Product Code
| BTA | Pump, Portable, Aspiration (Manual Or Powered) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-12-22 |
| Device Publish Date | 2023-12-14 |
Devices Manufactured by GI Supply, Inc.
| 00893029002731 - RenovaRP | 2023-12-22The RenovaRP® Centesis Pump is intended to be used in conjunction with the RenovaRP Tube Set and the RenovaRP Fluid Drainage Bags to remove ascitic fluid from the abdominal cavity for paracentesis, and remove pleural effusion from the thoracic cavity for thoracentesis. The RenovaRP Centesis Pump is intended to be used by medically trained healthcare professionals knowledgeable about paracentesis and thoracentesis. |
| 00893029002731 - RenovaRP | 2023-12-22 The RenovaRP® Centesis Pump is intended to be used in conjunction with the RenovaRP Tube Set and the RenovaRP Fluid Drainage Ba |
| 10893029002165 - RenovaRP Tube Set | 2022-08-18 RenovaRP Tube Set from GI Supply is intended to be used in conjunction with the RenovaRP Paracentesis Management System to remov |
| 10893029002592 - MoonPants SM | 2021-07-28 MoonPants SM single-use non-sterile garment |
| 10893029002608 - MoonPants ML | 2021-07-28 MoonPants ML single-use non-sterile garment |
| 10893029002615 - MoonPants XL | 2021-07-28 MoonPants XL single-use non-sterile garment |
| 10893029002622 - MoonPants Long | 2021-07-28 MoonPants Long single-use non-sterile garment |
| 00893029002670 - SportShorts XS | 2021-07-28 SportShorts XS single-use non-sterile garment |
| 00893029002687 - SportShorts SM | 2021-07-28 SportShorts SM single-use non-sterile garment |
Trademark Results [RenovaRP]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RENOVARP 86253836 4648701 Live/Registered |
GI Supply, Inc. 2014-04-16 |
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